510(k) · Cleared
ClearedScleral Plugs, 19 and 20 Gauge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Consultants, Inc. · LXP Plug, Scleral
Cleared on Jul 13, 1999 as substantially equivalent to K854507 (Storz Instrument Co., 1986) after a 119-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 13, 1999
- Review
- 119 days
- Class
- Class II
- Product code
- LXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854507 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854507 Storz MVS 19 & 20 Gauge Scleral PlugsStorz Instrument Co. · 1986
- This deviceK990872 Scleral Plugs, 19 and 20 GaugeOphthalmic Consultants, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854507 | Storz MVS 19 & 20 Gauge Scleral Plugs | Storz Instrument Co. | 1986 | — |
| 0 (this device) | K990872 | Scleral Plugs, 19 and 20 Gauge | Ophthalmic Consultants, Inc. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K854507 | Storz MVS 19 & 20 Gauge Scleral PlugsSummary page 1…igned: MD&M: 3“!# 19 A0 % 72~ 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS DEVICE NAME (Trade, common, and classification): Scleral Plug. PREDICATE DEVICE(s): K854507, et al, submissions, information attached, which were determined to be SE. DESCRIPTION: Scleral plugs, 19 and 20 ga., for use in… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K854507.
How does its category compare?
All LXP devicesLXP Plug, Scleral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXP
FDA has decided no LXP device since 2007.
Median 510(k) review, days · LXP
Too few LXP 510(k)s in any year since 2007 to give a median.
Recalls per year · LXP
No recall names LXP since 2007.
Adverse event reports per year · LXP
No MAUDE report names LXP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously, made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990872 · printed Nov 3, 2026
Cite this page
510(k) Report. “K990872: Scleral Plugs, 19 and 20 Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K990872
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026